Evaluation of Treatment Efficacy of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea

Not Applicable

Terminated

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: FPH Device with SensAwake On + Pressure Support B; Device: Competitor's PAP Released Device + Pressure Support A; Device: FPH Device with SensAwake On + Pressure Support A; Device: FPH Device with SensAwake Off + Pressure Support A; Device: FPH Device with SensAwake Off + Pressure Support B; Device: Competitor's PAP Released Device + Pressure Support B

• Registration Number: NCT02971436
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

This study will investigate the efficacy of the FPH modified positive airway pressure (PAP) device with or without SensAwake; and with different pressure support in OSA participants; in both an in-home and in-lab environment. Comfort, compliance and the accuracy of the pressure delivery will also be evaluated. The FPH device will be compared to a market released product.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-17
• Study First Submitted QC: 2016-11-18
• Study First Posted: 2016-11-23
• Study Start: 2016-12
• Primary Completion: 2017-08-31
• Study Completion: 2017-08-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Aged 18 and over
• Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) - (Continuous Positive Airway Pressure (CPAP) or AutoCPAP). Participants can be naïve to CPAP or experienced users of CPAP.
• For experienced users of PAP (CPAP or AutoCPAP): Using the PAP of more than 4 hours/night for 70% during the last 30 days (justification allowed by the investigator)

Exclusion Criteria

• Contraindicated for PAP (CPAP or AutoCPAP) therapy
• Persons with other significant sleep disorder(s) (e.g periodic leg movements, insomnia, central sleep apnea)
• Persons with obesity hypoventilation syndrome or congestive heart failure.
• Persons that require supplemental oxygen with their PAP (CPAP or AutoCPAP) device
• Persons with implanted electronic medical device (e.g cardiac pacemakers)
• Persons who are pregnant or think they might be pregnant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FPH Device with SensAwake On + Pressure Support B	FPH Device with SensAwake On + Pressure Support B	FPH Device with SensAwake On + Pressure Support B
Competitor's PAP Released Device + Pressure Support A	Competitor's PAP Released Device + Pressure Support A	Competitor's PAP Released Device + Pressure Support A
FPH Device with SensAwake On + Pressure Support A	FPH Device with SensAwake On + Pressure Support A	FPH Device with SensAwake On + Pressure Support A
FPH Device with SensAwake Off + Pressure Support A	FPH Device with SensAwake Off + Pressure Support A	FPH Device with SensAwake Off + Pressure Support A
FPH Device with SensAwake Off + Pressure Support B	FPH Device with SensAwake Off + Pressure Support B	FPH Device with SensAwake Off + Pressure Support B
Competitor's PAP Released Device + Pressure Support B	Competitor's PAP Released Device + Pressure Support B	Competitor's PAP Released Device + Pressure Support B

Primary Outcome Measures

Name	Time	Method
Apnea Hypopnea Index (AHI)	1 night	Through the polysomnography

Secondary Outcome Measures

Name	Time	Method
Device Triggering	1 night	Through the polysomnography
Therapy Comfort	3 nights	Through a subjective questionnaire
Compliance	3 nights	Through the device and independent flow logger

Trial Locations

Locations (2)

Fisher & Paykel Healthcare; 🇳🇿 Auckland, New Zealand

WellSleep Centre; 🇳🇿 Wellington, New Zealand